Subject: Specialty Quantity Limit Thalomid 2389-H P2025

Drug

THALOMID  (thalidomide)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. If the member’s plan allows a quantity limit exception review for the requested medication, coverage of an additional quantity may be provided up to the exception limit with prior authorization. The recommended dosing parameters for all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

Covered Quantities

Exception limit to address chronic graft-versus-host disease (GVHD).

Medication	Standard Limit	Exception Limit
Thalomid (thalidomide) capsules 50mg	28 per 28 days	Not applicable
Thalomid (thalidomide) capsules 100mg	112 per 28 days	336 per 28 days

FDA-Recommended Dosing

Multiple myeloma

200 mg orally once daily

Erythema nodosum leprosum (ENL)

100 to 300 mg/day for an episode of cutaneous ENL

Up to 400 mg/day for severe cutaneous ENL

Place of Service:

Outpatient

The above policy is based on the following references:

1. Thalomid [package insert]. Princeton, NJ: Celgene Corporation; March 2023.
2. AHFS Drug Information. (Adult and Pediatric) Bethesda, MD. American Society of Health System Pharmacists, Inc. Electronic version, Updated September 17, 2025. Available with subscription. URL: http://online.lexi.com/lco. Accessed October 2, 2025

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

April 18, 2026